Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA)

NCT01255111 | Completed

• 1 other identifier: 2010AC1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure. AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory. PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep. EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.

Conditions

Chronic Respiratory Failure

Keywords

Chronic respiratory failure; Noninvasive ventilation; Patient-ventilator interactions; Sleep; Sleep fragmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic respiratory failure at stable state who are indicated to domiciliary noninvasive ventilation

You may qualify if:

• Chronic respiratory failure with indication to domiciliary NIV according to the international guidelines.

You may not qualify if:

• Decompensated respiratory failure attested by a pH \<7.35,
• Modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection,
• Respiratory frequency \>30/min.

Sponsors & Collaborators

• Groupe de Recherche sur le Handicap Respiratoire: lead

Study Sites (1)

Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Pr. Antoine CUVELIER, MD, PhD

  Groupe de Recherche sur le Handicap Ventilatoire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2010
• First Posted: December 7, 2010
• Study Start: October 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

FR (1)